The following data is part of a premarket notification filed by Guangzhou Sonostar Technologies Co., Ltd. with the FDA for C5 Diagnostic Ultrasound System.
| Device ID | K171926 |
| 510k Number | K171926 |
| Device Name: | C5 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Guangzhou Sonostar Technologies Co., Ltd. 504#, C Building, #27 Yayingshi Road, Science Town Guangzhou, CN 510665 |
| Contact | Weizhong Cai |
| Correspondent | Helen Nan Wenzhou Cytech Information Service Co., Ltd. Room302, NO.21 Building, Kaiyu Garden Xishan South Road Wenzhou, CN 325000 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-27 |
| Decision Date | 2017-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970672750012 | K171926 | 000 |